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Pre-Klenz 2D66J4

by Steris Corporation EUDAMEDGUDID

Active European Union

Ref 2D66J4Model Pre-Klenz Soak Shield

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995SLPKLENZSKSHLD7W Basic UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number50724995218855 UDI-DIDate25 Mar 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Pre-Klenz
Generic Name
Medical device cleaning agent
Model / Ref / Catalog
2D66J4, Pre-Klenz Soak Shield
Primary DI / UDI-DI
50724995218855
Basic UDI-DI
0724995SLPKLENZSKSHLD7W
Unit of Use DI
00724995218850
FDA Product Code
FLG
EMDN Code
D99 Disinfectants, antiseptics, sterilising agents and detergents for medical devices - other
GMDN Term
Medical device cleaning agent
Device Class
Class I
Regulation Number
880.6150
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution

Other devices from Steris Corporation

See all devices from Steris Corporation →

Properties

  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No